An edition of Guidance for FDA reviews and sponsors
(2008)
Guidance for FDA reviews and sponsors
content and review of chemistry, manufacturing, and control (CMC) information for human gene therapy investigational new drug applications (INDs)
by Center for Biologics Evaluation and Rese...
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Gene therapy, Drug approvalPlaces
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Guidance for FDA reviews and sponsors: content and review of chemistry, manufacturing, and control (CMC) information for human gene therapy investigational new drug applications (INDs)
2008, U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research
electronic resource :
in English
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Edition Notes
Title from title screen (viewed on Apr. 24, 2009).
"April 2008".
Includes bibliographical references (p. 32-34).
Mode of access: Internet at the GPO Web site. Address as of 4/24/09: http://www.fda.gov/cber/gdlns/gtindcmc.pdf ; current access is available via PURL.
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| December 13, 2022 | Created by MARC Bot | import new book |